Telaprevir and FDA Approval: The Race is On for New Hepatitis C Drugs

Liver Specislists of Texas-HCV Research

For those of us that are involved in the care of patients with chronic hepatitis C, the “never too soon” announcement that we will finally have new drugs to treat our hepatitis C patients with cannot come soon enough. There is a real possibility that one and possibly two new agents for hepatitis C will be granted approval by the FDA in the months to come. When that day will be is unknown to me, but I anticipate later this summer at the latest.

There is a frenzy of discussion in the press, as well as the blogosphere on the new drugs, namely Telaprevir, manufactured by Vertex, and Boceprevir, manufactured by Merck. I have had the opportunity to use both of these drugs in clinical studies over the past several years, and understand how they both work, and what patients can expect. Much to everyone’s surprise, patients will still need to take one of the pegylated interferons once weekly, and ribavirin twice daily. The new drugs are added to this backbone of therapy. Besides the expected interferon and ribavirin side effects, the protease inhibitors do add some additional problems, but for the most part, in experienced hands, they can be managed fine. Once these drugs are approved, I anticipate a mad-dash of patients, wanting to get their hands on these therapies.

My advise is to start requesting your old records now if you were previously treated. Knowing exactly how many weeks you were treated, what your response was, and what complications developed, will be important information prior to commencing any sort of new therapy, regardless of which protease inhibitor you are started on. It can take weeks to get these records, so start asking now.

There are hundreds of thousands of patients with hepatitis C that are either naive to therapy (never treated), or previously treated with a partial response (null responder, non-responder, or responder-relapser). All of these individuals should be considered for these new therapies, but you need to be sure you are being seen by a practice that can handle these patients. With the new protease inhibitor drugs, resistance can become an issue, and discontinuing the therapy in a timely fashion is important. The treatment protocols are different from prior therapies, with a lead-in phase with interferon. All of these steps requires careful monitoring and communication with the patient. An experienced staff of nurses will be needed. Prior to being evaluated for these new exciting drugs, you, as a consumer, need to ask these questions to see if your care provider has the necessary experience, as well as a dedicated team to support them once patients are started on therapy.

Besides the two contenders for FDA approval later this summer, the pipeline for additional drugs is incredibly long. We are conducting research studies on an additional 12 drugs, all of which look promising. Some of the protocols are free of the hated interferon. Imagine, HCV therapy without interferon? That day will be here, allbeit several more years. I am currently in Chicago with the HCV team from Abbott, who also has a number of exciting compounds we will start studying soon with our patients in Houston.

So, when will the new hepatitis C drugs be available? My best educated guess will be by Labor Day, but we may all be surprised sooner, based on the chatter in the press and FDA hallways.

I am eager to hear what you think? Comment on your prior experience with hepatitis C therapy.

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69 Responses to “Telaprevir and FDA Approval: The Race is On for New Hepatitis C Drugs”

  1. John 03/06/2011 at 11:30 pm #

    What do you think of teleprivar trials? My doctor told me to wait and not get into a trial because I am a non responder and that I can get a resistance. Do you agree?

    • Dr. Joe Galati 03/15/2011 at 10:07 pm #

      Tough question. If you have never been exposed to a protease inhibitor, and you are a non-responder, re-treatment is an option to seriously consider.

      • Jack 04/02/2011 at 3:36 pm #

        I have hcv 1 and hemacromatosis I am a relapser whats my chance of telaprevir working for me?

    • Dr. Joe Galati 03/30/2011 at 11:27 pm #

      Not really. The data on retreatment suggests a 65% SVR for this group. With all of the new agents, attention to response early on (4-8-12 weeks) is important to prevent the development of mutations. Consider therapy. Good luck.

  2. Vivi 03/25/2011 at 8:05 pm #

    I have HCV /cirrhosis I am geno type 1 africa-american female I has 48 weeks of interferon and ribavin Had my last injection May 12 2010 I had a relapse the treatment only suppressed the hcv I am going to try the new drugs in April or May this year I hope to become a spoke person for the treatment to help other africa-American woman. because we are never tested for this I have never drink or smoke ,but I had a blood tranfusion in 1980 and I have work in a Lab environment processing specimens including blood etc. for about 20 yrs I also have a tatoo which I was told you can get hcv from tatoos I have a wonderful Dr. and go to a great liver clinic I took injections for hep a and b even when I was employed .

    • Dr. Joe Galati 03/30/2011 at 11:25 pm #

      Excellent. You make some very good points. The research on re-treatment looks very promising. Additional therapy following these are even more exciting to research. Good luck.

  3. Jody E Jackson 03/29/2011 at 1:59 am #

    I have Hep C 1 and currently living in Jakarta Indonesia. I am going back and forth to Singapore for check ups and wonder if I will need to stay in Houston for treatment or could my Singaporean doctor dispense the medicine for me? I have had Hep C for approximately 20 plus years, I am 52 years old and have never been treated for Hep C. Houston is home for me, so I would like to be seen when I return in June.
    I thank you for any help you can give to me,
    Regards,
    Jody Jackson

    • Dr. Joe Galati 03/30/2011 at 11:23 pm #

      I am sure these agents will be available world-wide. Of course, if you’d like to be evaluated in Houston that can always be arranged. Let me know how we can assist.

  4. Cheryl Sharpe 03/31/2011 at 9:14 pm #

    My husband received a new liver 8/21/2006 after suffering from Hepatitis C for 12 years. He
    failed an initial interferon trial soon after being diagnosed in 1994, was told he was a “non-responder”.

    His Hepatitis C has placed him in Stage 3 of liver failure and, with no other hope, agreed to undergo the “new generation” interferon treatment, Pegasys and ribavirin.

    He began treatment on 3/22/11. Today, 3/31/11, after only two shots, he said he cannot continue to take this treatment, that he would rather die sooner than live feeling like this. He has been constantly nauseous, has chills, feels like his eye sockets are on fire, body aches similiar to the feeling you get when you have pneumonia, (like you need to be hospitalized), lethargic,has done no more than get up to use the restroom, literally.

    Needless to say he has used the term “giving up” and is convinced this treatment can, in no
    way be “helping him” that it has to be “hurting him” because the side effects are so severe.

    He said that even the liver transplant surgery didn’t make him feel this bad. We’re desperate, can you offer any hope?

    Sincerely
    Cheryl Sharpe

    • Dr. Joe Galati 04/01/2011 at 4:57 pm #

      In many cases, I have seen that patients do not tolerate the interferon as well after transplant as they may have before their transplant. In general, we start dosing the interferon and ribavirin and lower doses, and slowly increase to see how they tolerate the medicine. Too much too soon may cause the result you described. Every patients is different as to how they respond. Some actually have no reportable side effects.

      I’d talk with his doctor and see if a reduced dose can be tried. The option to wait until the protease inhibitors are FDA approved and available is an option as well, though interferon is still part of the therapy. Good luck. If in Texas, we can always take a look.

  5. Jack 04/02/2011 at 3:47 pm #

    I have hcv 1 and hemachromatosis I’m a relapser. my Dr is hopeful the telaprevir will work for me. have you had any patients with both?

    • Dr. Joe Galati 04/07/2011 at 10:13 pm #

      I have. The approach is to make sure the iron is removed first, prior to starting the HCV therapy. Donating blood (phlebotomy) until the iron levels is down usually results in a better response to the HCV therapies.

  6. Kurt Stolba 04/08/2011 at 9:24 am #

    I’m a 57 year old white male and I tested positive after numerous tranfusions for TTP in 1989. I started treatment last year but had to stop after 24 weeks because of relapse. Will the new treatment really help me? I’m one of the lucky ones to have very few side effects. Thanks.

    • Dr. Joe Galati 04/21/2011 at 10:08 pm #

      Yes indeed. We are all excited about treating such patients as yourself. Good luck. Let us know if we can assist you.

  7. Patrica 04/08/2011 at 11:55 am #

    I am a hep C person, was a level 1 for many years, but after a recent biopsy, I am now a level 2, with Geno type 1, all my other levels are good and I feel and look good. I completed the treatment last year (66 wks) and rided the virus only to have it come back after 2 months. Now I have been asked to be in a study for TMC 435. Of course, there is a chance I may get the placebo. Should I take the study drugs or just wait for the telaprevir/boceprevir? My specialists are telling me this TMC 435 is a step up from telaprevir and boceprevir. Your thoughts???

    • Dr. Joe Galati 05/14/2011 at 8:08 pm #

      It is true that there are a number of excellent drugs in the HCV pipeline. It may be worth looking into further.

  8. Dagmara Bienko 04/11/2011 at 4:07 pm #

    I stopped treatment after six monts due to cervical cancer(in situ) diagnosis. I was rapid responder and remained negative after 6mo. After total hysterectomy my doctor prescribed estrogen spray,but I belive in bioidentical replacement terapy. What is your opinion on replacement terapy for women in menopause? I will go back for test in June and I hope I am still negative.

  9. Ellie Hogan 04/12/2011 at 10:54 am #

    Hello, Great news about these new drugs. My Dr. told me about them at my last annual check up. I have had hep-c 1a, for at least 20 – 35 years. No real symptoms. No elevated enzymes. My liver is thus far functioning fine. However, I did try tx during 2005-2007 (pegeses-copeges) interferon-ribavirin for 88 weeks. That’s right 88 weeks. I did not clear the virus until somewhere between week 36-40, but with each months blood test my viral count dropped a log. I tolerated tx so well my Dr. let me stay on it to see what would happen, also I did not have insurance so my tx was not stopped. I cleared the virus by week 40, the consensus of ‘the ‘tx protocol powers-that-be’ recommended I do another 48 weeks. Which I did. It was all doable. I had to plan ahead, eat right, drink plenty of water, never miss a med. and exercise. The virus was detected as back on my first months check. I still feel fine, my Dr. says it’s up to me if I want to try this new drug. He says I would not have to wait so long to find out if it was going to work or not this time. Is that right? I do have some spider angiomas and when pressed hard my liver is tender. I would like to be rid of this disease if I can be. Do you think I am a candidate for tx? Will there be help with the cost of meds from the pharmaceutical company’s for those of us who do not have Insurance and do not have high incomes to pay with?. I was helped with the cost of the drugs during the last tx. I just had to pay all the Dr’s and labs etc. Which came to a substantial amount after 88 weeks. I am not sorry I tried. I’m considering trying again. I look forward to your response. Thank you. Ellie

    • Dr. Joe Galati 05/14/2011 at 8:05 pm #

      Without knowing all of the details of your case, re-treatment should be considered. Boceprevir was approved yesterday.

  10. Renee 04/12/2011 at 6:35 pm #

    Hi, Dr.Galati, my fiancé is at stage 4 hep c. He only had an ultra sound and no other type of treatment to confirm his diagnosis. He feels he has been misdiagnosis, but at the same time he does have allot of symptoms. One which is memory and mood swings, he was on the inferon treatment for 3 months and was taken off it, from his doctor, he was no responding. He is waiting for the new med. coming out. My concern is the he is not at the stage level they tell him he is in. He is a very strong active persons, is on the heavy side, but at the same time he is uncertain of his condition. Should he get on this new med. or should he get a complete work up or a second opinion about his diagnosis.

    Thank you

    • Dr. Joe Galati 04/14/2011 at 12:05 pm #

      A second opinion is never a bad idea. The key data to have is the liver biopsy, and the liver tests (blood work). It would be a good idea to consider the new therapies once available, or think about participating in a clinical trial. Good luck.

    • Dr. Joe Galati 05/14/2011 at 8:03 pm #

      Boceprevir was approved yesterday.

  11. John C. 04/19/2011 at 1:18 am #

    I was very pleased upon reading the information here. Despite degrees in Math and CS, not to mention designing/developing a laboratory information system twelve years ago for a client I still service today, when it comes to modern day computer technology I am a dinosaur. My point being I might not be able to figure out how to send my comment or whether I get a response. Today I am disabled with debilitating psoriatic arthritis of which I am stricken with the worst variety one can have. Having later contracted HCV and fortunate enough to be treated by a very capable doctor and staff, I went through interferon/ribaviron treatment from July 2009 thru March 2010 at which point it was determined I was a non-responder. I was so excited when my viral load went negative in December 2009 only to have it start climbing back up in February 2010. I am told there has been no testing, hence no info/stats, with Telepravir on non-responders. Although sometimes as hard as I try I do not listen well. The treatment took its toll on my body due to the auto-immune disorder, and when I went off treatment I got the worst attack of psoriasis ever covering 80% of my body and needing UVB treatment which thankfully worked. I am SO interested in being a candidate for treatment of non-responders with Telepravir, especially if they also want info on how it affects those who also suffer from auto-immune disorders. The problem is I am lost when it comes to keeping abreast of such information or how to go about finding details on this type of research. My doctor is concerned with how my system will take a second round of treatment considering what I went through in the first round. Anything you could do to point me in the right direction in light of the details I’ve shared would be fabulous.

  12. Kelly 04/21/2011 at 12:52 pm #

    Dr. Galati:

    I have had active HCV for at least 2 years. I am currently on the standard Pegasys/Ribivarin treatment. My viral load never has gotten below 90,000 but my doctor insists I stay on it for 3 more weeks. I must tell you that I am in Italy at the moment with my military spouse and the Italians approved the Telapravir & Boceprivie (sic) on the 19th of April. However it will not be commercially available until at least late September. In the meantime my wife is leaving the Army as well as it’s benefits. My question is how do I get involved in a clinical trial in the Dallas area as we will be leaving Italy probably in October at the latest?

    I must also include that my genotype is 1 and they have done a marker test which provided little to help my situation. I really don’t want to go through a biopsy again or more blood tests to start a new diagnosis once I get back to the States. As the Italian medical system is quite a bit different than the give and take of an American doctor/patient relationship, it is quite difficult to get straight answers from them. The Army has only one infectious disease department which is in Germany…blah blah blah..it is difficult to get answers as to what to do once we leave Italy. Any suggestions???

  13. Kelly 04/21/2011 at 12:53 pm #

    I have had active HCV for at least 2 years. I am currently on the standard Pegasys/Ribivarin treatment. My viral load never has gotten below 90,000 but my doctor insists I stay on it for 3 more weeks. I must tell you that I am in Italy at the moment with my military spouse and the Italians approved the Telapravir & Boceprivie (sic) on the 19th of April. However it will not be commercially available until at least late September. In the meantime my wife is leaving the Army as well as it’s benefits. My question is how do I get involved in a clinical trial in the Dallas area as we will be leaving Italy probably in October at the latest?

    I must also include that my genotype is 1 and they have done a marker test which provided little to help my situation. I really don’t want to go through a biopsy again or more blood tests to start a new diagnosis once I get back to the States. As the Italian medical system is quite a bit different than the give and take of an American doctor/patient relationship, it is quite difficult to get straight answers from them. The Army has only one infectious disease department which is in Germany…blah blah blah..it is difficult to get answers as to what to do once we leave Italy. Any suggestions???

    Your comment is awaiting moderation.

    • Dr. Joe Galati 05/14/2011 at 8:01 pm #

      The first of the protease inhibitors has been approved as of yesterday. Boceprevir will be available to all very shortly.

  14. Hashaam Akhtar 05/01/2011 at 12:34 am #

    Hello Dr. Joe.
    I am a Ph.D scholar and I am working on interferons. I wanna ask you comments regarding interferon Lambda (it is a type iii IFN with hetrodimer of its receptors, which make it quite specific for its antiviral actions.)

  15. Rick 05/13/2011 at 8:58 pm #

    Dr. Galati,

    First of all, thank you for providing this valuable resource. We have a family member with HCV that could not tolerate interferon due to terrible side effects. What would the risks/concerns be with monotherapy with one of the new agents?

    Thanks in advance…

  16. Richard G. 05/18/2011 at 10:52 am #

    I am a healthy 62 yo who has likely been HCV 1a + for 35 years. I first became aware of this 2.5 years ago. A biopsy 2 years ago was 2/2. I am trying to decide if I want to get treated or continue to wait for better options, knowing that increased age is a negative predictor or success. Any thoughts on how to measure the progression of the disease? I understand that liver enzymes rise and fall and that viral load is not a particularly good measure. Also, my hepatologist left private practice to do research at NIH–any names in the DC area that you like? I saw a gastroenterologist who basically ran a colonoscopy factory and was not comfortable with him.

    Excited about newly available treatment. and thanks for any help you can offer.

    • Dr. Joe Galati 05/19/2011 at 12:08 am #

      The new agents are excellent, especially if you are naive. I’d seriously consider treatment, or consider a clinical trial.

  17. HeatherS 06/06/2011 at 10:13 am #

    My husband was treated for hep c in 2005 with interferon/ribaviran. After 3 mnths, his viral load was undetectable, but 3 mnths after finishing treatment it was again detected. He has no liver abnormalities yet, but has since suffered renal failure and is on home p.d. His nephrologist suspects the kidney disease may be linked to the hep c. What complications could there be with renal failure and treatment with telaprevir?

    • Dr. Joe Galati 06/11/2011 at 10:17 pm #

      The treatment issue really centers around the ribavirin, that is cleared by the kidney. To use the protease inhibitors, you need to use all three medicines (interferon/ribavirin/protease inhibitor). In renal failure, ribavirin is a stickler.

  18. joe 06/06/2011 at 1:13 pm #

    Do you expect the new meds to be approved for post liver transplant patients?

    Thanks

    • Dr. Joe Galati 06/11/2011 at 10:15 pm #

      Right now they are not approved due to drug-drug interaction. The drugs to prevent rejection will get to very toxic levels causing severe complications. Further research in needed. In the pipeline, there are new drugs being developed, we hope with less interactions.

  19. FanC 06/11/2011 at 12:40 pm #

    I currently have hep c resulting in cirrohsis and early late last yr I was diagnosed with liver cancer. I have a dime size tumor. With me being on the chemo pills am I a candidate for the teleprevir treatment? Would I need to stop my chemo pills to do so?

    • Dr. Joe Galati 06/11/2011 at 10:13 pm #

      HCV therapy may be a good idea. There is research showing the interferon is anti-tumor as well. Anything to rid you of HCV is a good idea-if you can tolerate it. Liver transplant should also be considered now that a cancer is present.

  20. Robert Stein 06/26/2011 at 12:43 pm #

    Dr.Galati, I am a male Caucasian 59 yrs. of age. My genotype is 1A,
    Friday i am going for a biopsy U. of Miami.Dr.s Levi and Dr. Moon surgeons. I am 3 years post TX and feel great. My numbers also are looking good but my first year we lowered the dosage of the Prograff and Cellcept rather quickly and my numbers started to escalate.I had to do a biopsy at that time. We increased the drugs and my numbers all came back fine. I test approx. once every 6 to 10 weeks. Now they are telling me that i am already at stage 3 even though my numbers are not increasing. If they knew from the first biopsy that i was stage 3, why do you think they waited an additional 2 years? I understand that question probably can’t be answered.
    They do not give direct responses and i understand why that is but it is also frustrating.
    If there is more scar tissue now, then they want to place me back on treatment.
    The first time i had treatment was when they first came out with once a week Peg, without Ribavarin. Which of course i was a non responder. If this upcoming biopsy shows that there is more scaring and i need treatment, i am not sure what to do because the response rate is so poor for my genotype.Plus if i don’t do treatment i will not be eligible for another TX. Any suggestions?
    Thanks and i appreciate any and all thoughts.
    Bob

    • Dr. Joe Galati 07/18/2011 at 11:43 pm #

      Thanks for the note. Unfortunately, the new Protease Inhibitors cannot be used for transplant patients, due to toxic drug-drug interactions.

  21. KarmaL 07/24/2011 at 10:04 am #

    I am a 54 yr old female with genotype 1A, was in a study 10 yrs. ago with no results, anxious to start treatment and am in excellent shape, single Mom to triplet boys age 9. Is it now availABLE?

    • Dr. Joe Galati 07/24/2011 at 3:31 pm #

      Yes indeed. It would be nice if you had the medical records on the study you were in previously. Do you have access to a hepatologist in your area? Let me know if we can assist.

  22. Cheryl Sharpe 07/29/2011 at 12:05 am #

    We corresponded in April, 2011, when my husband (5yr post transplant), began Pegasys/ribavirin treatment. He has genotype 2b–even though he was a non-responder to interferon alone in ’95, his doctor advised he was in Stage 3 and recommended he try this new therapy. After the first 3wks his viral load dropped tremendously- 69million to 122thousand, then again down to 65thousand. At week 18 his viral load jumped back up to
    1million 520thousand and it appears his doctor is going to take him off treatment as a non-responder again. Are there any therapies/trials for non-responders? I can’t imagine just giving up–his liver enzymes are normal and he hasn’t developed anemia. Thank you so much for your time. Sincerely Cheryl

  23. Cheryl Sharpe 08/03/2011 at 5:08 pm #

    My husbands’ doctors’ assistant phoned to advise that Jim’s viral load went back down–to 113,000 but that the “RNA Log” reflects that he is a non-responder and wants him to go on
    “maintenance” interferon. We had never even heard the term, RNA, before. Could you explain, in layman’s terms, the correlation/difference between “viral load” and RNA? Is this change in treatment reasonable? He only has 4weeks left of a 24wk regimen and the viral load is dropping again. Thanking you for your time. Cheryl

  24. Ortsan 08/29/2011 at 12:07 am #

    Hello Dr, a family member has been diagnosed with hep C-1a , stage 1 . He did a test prior taking the regular Tx (riba and interferon) and came non responder… The question is….if he is a non responder, what is next? what should he do? I don’t know what to think…. Are the new drugs available for everybody or not? Please help to clear our minds….

    • Dr. Joe Galati 09/11/2011 at 1:38 pm #

      Yes indeed there are new drugs available for re-treatment, using the new FDA approved agents, or participating in ongoing research studies. If in Texas, we’d be more than happy to evaluate.

  25. kenneth hamilton 09/23/2011 at 10:56 am #

    what is the statis of treatment for post liver paciants

    • Dr. Joe Galati 10/01/2011 at 10:48 pm #

      Right now, the protease inhibitors are NOT indicated for transplant patients. Serious drug-drug interactions develop. Additional new drugs are being developed.

  26. Nicole 12/03/2011 at 5:43 pm #

    Hello. I was diagnosed hcv positive geno 1a when I was 18. I started the ribivirin and peg. I was on for about 6-8 months when I turned 19 my mothers insurance dropped me. I’m now 27 and looking into tx again but cannot afford it. I’m looking into clinical trials but they all were for never before tx. Is there anyway I can take legal actions on the insurance company that dropped me in mid tx? I’m struggling with quality of life I guess as the rest of the hcv people do. Please I need some guidance. My doctor doesn’t know much about any of this. Maybe I should change doctors.

    • Dr. Joe Galati 12/07/2011 at 10:33 pm #

      Research opportunities are certainly available. Let me know what area of the country you live and I can direct you to a center close to home.

      • angel 06/15/2012 at 12:22 pm #

        I am in Vancouver,BC. I am happy to relocate for trials that do not make people sick. What can you tell me?
        Thanks

        • Dr. Joe Galati 06/17/2012 at 11:20 pm #

          We have research trials that are better tolerated now. Come visit us in Texas.

    • glen 01/10/2012 at 7:23 am #

      your situation is sad, shameful and disgusting. Talk to an several attorneys–I think you have excellent grounds for a successful law suite against both the insurance company and the physician. They may take this case without payment from you until you have won in court; then they get a percentage of that.
      If what you say is true, cases such as yours should be punishable by jail time as well.

  27. FDA USA 01/02/2012 at 3:13 pm #

    You really make it seem really easy together with your presentation but I to find this matter to be really one thing which I think I would never understand. It seems too complex and extremely wide for me. I’m having a look ahead on your subsequent publish, I will attempt to get the dangle of it!

  28. glen 01/08/2012 at 8:57 am #

    Dr. Galati:
    I have had HCV almost 30 years; I’m a 48 y.o. male, and have taken the Fibrosure test which came back indicating cirrhosis with severe inflammation. I have high iron levels. I think my transferrin was around 800 and my serum iron was about 250. My hemochromatosis test came back negative but my Dr said its not 100% and suggested phlebotomy but said if I wanted I could start the new triple HCV therapy(Incivek) without the phlebotomy because it’s not known if the it really matters with new PI’s. I’m very confused and frustrated. I’ve been seeking treatment since summer and have only now found someone to treat me for 48 weeks due to the cirrhosis and detect my iron levels. I want to get the show on the road, but also want to do whats best.
    Do you think a second Fibrosure would be wise to see if the results are the same?
    I thanks you very, very much for answereing these question. I see that you are not only a good doctor, but also a very good person. God bless you.

    • glen 01/08/2012 at 1:28 pm #

      I made a mistake in my post above. My iron results are:serum iron–243, iron saturation–59, serum ferritin–803,transferrin–359.

      • Dr. Joe Galati 01/08/2012 at 9:04 pm #

        This is a lot of information. Certainly, if indeed you have cirrhosis, treatment is necessary, but can be a tricky move due to increased complications. How do you know you have cirrhosis? This is a key point.

        Iron overload, unrelated to hemochromatosis , is seen with chronic liver disease. Getting iron levels down first may be valuable, but I’d need to see all the tests to make an opinion. Alcohol use can raise iron levels as well.

        There are protocols with combination therapies ifor those with cirrhosis. We currently have such a protocol. If in Houston, let me know. Otherwise, let me know where you’re at and I can suggest a center. Good luck.

  29. glen 01/08/2012 at 9:22 am #

    I also want to mention that I have never been treated and that a interleukin test was performed which indicated I would not respond to interferon as well as some people.
    Does body weight have a relation to sustained response of these new drugs? I’m 6’4, and weigh 265 lbs. I’m about 40 lbs overweight. I realize for many reasons I should lose this excess and I am working on it( I was 280) . My suger levels are normal.

  30. Kim 01/24/2012 at 7:32 pm #

    The week after telep. was FDA approved I started treatment for the first time on this hep I have had for 20 years.
    Just completed 6 months of telep.with inter. and rib. had a viral load of 13 million. in 4 weeks NONE!!!! No viral load for the next 5 months. 2 weeks after treatment-viral load 25,000. Dr. can’t understand- had blood work repeated- I was pretty devastated. I am not doing it again- I am in remission (6 yrs) from splenic marginal zone lymphoma- have had the hep c for 20 years- Upon research of the type of lymphoma I had- 25% had hep C also- so thoughts were that the hep might be the primary disease. So, since lymphoma usually returns, either more aggressively or in a different form, if I got rid of the hep, I may never have a re occurance of the lymphoma? I will know next week- I don’t believe it was a lab error- I will wait 10 years until there is a magic shot that will make it all go away…..I am 3 out of 40 so far that didn’t make the 6 month viral free point. Dag Gone It!

  31. J Wailer 03/21/2012 at 9:57 am #

    Dr,

    I have ITP and contracted Hep C from the transfusions I received. Do these drugs endanger those of us with auto immune disorders?

    • Dr. Joe Galati 06/01/2012 at 5:41 pm #

      It is a delicate balance treating those with autoimmune disorders.

  32. Patricia 05/11/2012 at 3:39 pm #

    Dr Galati: Can botox harm your liver?

  33. angel 06/15/2012 at 12:16 pm #

    I have had Hepatitis C for more than 18 years. I have never had symptoms. I have had slightly elevated Alkaline phosphate and slightly elevated ALT. However, I have found out that the Lorazepam I have been taking for years can elevate those liver functions. Also, the ratio-proctozone can cause swelling in ankles. I detoxed from the Lorazepam and also the ratio-proctozone. The swelling is gone from my ankles. I am not sure if the liver functions improved yet as I have not tested since going off the drugs. I have never been treated. I am genotype 1a. Now that teleprivar is an option I was thinking of trying the 3 drug treatment, only to find out they put you on the same feared peg-interferon for most of the treatment. I am a single mom and I do not want to be laying in bed with vomitting, diarhea, insomnia, feeling like bugs are walking around in my body and so many of the side effects I hear of that torture people. I would really prefer to wait for a drug that does not harm people. Also, I have heard of people getting cancer while on peg-interferon. I believe that peg-interferon attacks all organs in the body and not just the hepatitis C. People get other health problems after being on this horrible drug. I am healthy right now except that hep c shows up in my blood test. The government runs the test here and will not allow the patient access to qualitative results. In the past, when I was allowed these results, they showed low levels of the virus and that doctor at that time(no longer in practice here) said “you have it but you are not sick with it. So on and live a normal life. ” She said the peg-interferon is worse than the disease itself. So I went about my life enjoying life and not worrying about it. Then I heard they had this new drug. Only to find out it is a longer run with the dreaded drug. I don’t think that is much better at all.
    How long before they have a drug that will not hurt people in the process? I feel it would be like trading hep c which doesn’t bother me at all, for possible cancer and at the very least laying sick in bed for 6 months.
    What can you tell me?
    Thanks

  34. soul 06/28/2012 at 11:19 am #

    Hi doctor, since 1997 i have been suffering from a mistrious disease which is any smell or odur gets into my stomach as result i have flautus always and sometimes i do not feel it when it gets out but wherever i stay in any room , it stinks or the room will have a bad smell. it is hard to belive and i have tried a lot to get a help but nobody willing to belive such a thing. i did not give up, i belive somewhere, somebody has an answer for my suffering please if you have any idea , please help me i really need your help. God bless you

  35. Katie 07/11/2012 at 10:22 pm #

    I have been diagnosed with Hep C for 3 yrs and am extremely interested in doing a clinical study. I live in the Dallas area, it would be great if you could guide me in the right direction. Thanks (:

    • Dr. Joe Galati 08/11/2012 at 4:30 pm #

      The Dallas area has research sites; here in Houston you can call our office for an evaluation 713-794-0700.

  36. Bella 06/28/2013 at 10:57 am #

    Hello Doctor,
    My relative has infected Hepatitis C for almost 10 years. He frequently visit doctor twice a year. until this last two years, doctor said the virus in blood keep increasing, and now it’s up to 90,000. At this situation, should we make decision on treatment or not?

    Looking forward to hearing your reply.

    Thanks you very much.

    Best Regards,
    Bella

    • Dr. Joe Galati 07/24/2013 at 8:29 pm #

      The decision to treat is based more than viral load. Biopsy, and overall status of the patient is important. If in Texas, we’d be glad to evaluate for a possible research study.

  37. Tina Hernandez 09/07/2013 at 4:53 pm #

    I need a doctor to check my viral load the last time I had it checked was in 2000 and it was over 90000. the medication dropped it to 10000 in 4 months can you help me

    • Dr. Joe Galati 09/29/2013 at 7:57 am #

      We are available to assist. Contact our office at 713-794-0700 and ask for Lexa and she can get things rolling.

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